Regulatory Consulting Services

Gain flexible staff capacity to meet regulatory milestones

In today’s rapidly changing life sciences environment, it’s tougher than ever for pharmaceutical companies to keep pace with evolving regulatory requirements and shrinking submission timeframes. These factors exert ongoing pressure on companies of all sizes – from growing market leaders, up to the largest, most established organizations.

With major milestones on the horizon, and new ones emerging in real time, regulatory teams often require specialized external resources to meet critical deadlines in your drug development life cycles and manage peak demand. Klein Hersh can address your pressing functional needs and seamlessly augment your team, by providing access to experienced regulatory affairs consulting professionals on an interim staffing basis.

Executive Regulatory Consulting Specialists

Klein Hersh can address your pressing functional needs and seamlessly augment your team, by providing access to experienced regulatory professionals on a contract basis. When your staff resourcing levels need extra support, Klein Hersh delivers the flexible capacity you require to manage due diligence and hit your global regulatory milestones, while keeping your in-house professionals focused on strategic, growth-oriented functions.

How We Are Different from other Regulatory Consultant search firms?

Klein Hersh is ideally-suited to meet your regulatory consulting and interim staffing needs. Our

deep relationships in the regulatory professional community, honed through nearly 20 years in executive search, provide us with substantial reach to highly-skilled professionals.

For Clients in need of risk and regulatory consulting assistance

Klein Hersh leverages our best asset – our unmatched talent pool – to efficiently and cost effectively deliver the quality resources you need to meet a broad range of domain requirements, manage non-core activities, bridge the gap during staff changes, or provide interim regulatory leadership. Klein

Hersh can even assemble entire teams to tackle complex, longer-term regulatory requirements, while also providing support for multiple staffing assignments across product development life cycles.

When your staff resourcing levels need extra support, Klein Hersh delivers the flexible capacity you require to fill specialized domain needs and hit your milestones:

Regulatory Affairs Consulting
Leverage Klein Hersh’s vast talent network to find regulatory consulting professionals who can provide strategic regulatory affairs expertise. Find interim regulatory professionals who can lead or support FDA and global market filings and health authority interactions.
Regulatory Consulting CMC
If you are a growing pharmaceutical company or biotech, let Klein Hersh help you engage an experienced regulatory CMC consultant to lead or support filings of developmental or approved products – without the need for a full-time, in-house hire.
Product Labeling
Klein Hersh can you address all short term regulatory affairs needs easily and cost-effectively, including end-to-end labeling requirements via regulatory consulting expertise.
Advertising and Promotional Reviews
With the support of a dedicated regulatory consultant you gain technical knowledge and insight to achieve compliance with evolving regulatory requirements, including advertising and promotional claims of drug and biologics across therapeutic areas, as well as medical device products.
Regulatory Strategy and Operations
With the support of a dedicated regulatory consultant you gain technical Let Klein Hersh help you augment in-house staff so they can better focus on core growth activities. Regulatory consultants provide the flexible capacity to outsource key functions and gain highly-specialized, technical expertise for complex projects.

To learn more about our interim staffing and consulting services, please contact:

rsz 2zachZachary Spitz
Senior Director, Regulatory Affairs
267.948.1429
zspitz@kleinhersh.com